Maybe our resident Doc(s) can chime in? Again, I’m thirsty for good news. This may be a big deal (I’m not a scientist), so here’s the whole thing:
WHOOP WHOOOP WHOOP ALERT ALERT ALERT
Actual vaccine study data
Not a press release, preprint
Data on BioNTech/Pfizer's vaccine candidate
-45 participants injected, 3 dosage arms
-neutralizing antibodies tested for and observed at levels greater than convalescent serum:
"Neutralization titers were measurable after a single vaccination at Day 21 for all dose levels. At Day 28 (7 days after Dose 2), substantial SARS-CoV-2 neutralization titers were observed. The virus neutralizing GMTs after the 10 μg and 30 μg Dose 2 were, respectively, 1.8-fold and 2.8-fold the GMT of the convalescent serum panel. Assuming that neutralization titers induced by natural infection provide protection from COVID-19 disease, comparing vaccine-induced SARS-CoV-2 neutralization titers to those from sera of convalescent humans quantifies the magnitude of the vaccine-elicited response and the vaccine’s potential to provide protection. "
-pain at injection site most common side effect but there were plenty of side effects, mostly mild and resolving (this is actually a sign of an effective vaccine, provided it's within tolerable bounds)
-highest dose cohort only 1 injection due to side effects
On to Phase III! "While our population of healthy adults 55 years of age and younger is appropriate for a Phase 1/2 study, it does not accurately reflect the population at highest risk for COVID-19. Adults 65 years of age and over have already been enrolled in this study and results will be reported as they become available. Later phases of this study will prioritize enrollment of more diverse populations, including those with chronic underlying health conditions and from racial/ethnic groups adversely affected by COVID-19"
Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report
Mark J. Mulligan, Kirsten E. Lyke, Nicholas Kitchin, View ORCID ProfileJudith Absalon, Alejandra Gurtman, Stephen P. Lockhart, View ORCID ProfileKathleen Neuzil, View ORCID ProfileVanessa Raabe, Ruth Bailey, Kena A. Swanson, Ping Li, Kenneth Koury, Warren Kalina, David Cooper, Camila Fonter-Garfias, Pei-Yong Shi, Ozlem Tuereci, Kristin R. Tompkins, Edward E. Walsh, View ORCID ProfileRobert Frenck, View ORCID ProfileAnn R. Falsey, View ORCID ProfilePhilip R. Dormitzer, William C. Gruber, Ugur Sahin, Kathrin U. Jansen
We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among healthy adults, 18-55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 μg, 30 μg, or 100 μg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a panel of COVID-19 convalescent human sera. These results support further evaluation of this mRNA vaccine candidate.
......
These clinical findings for the BNT162b1 RNA-based vaccine candidate are encouraging and strongly support accelerated clinical development and at-risk manufacturing to maximize the opportunity for the rapid production of a SARS-CoV-2 vaccine to prevent COVID-19 disease.
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Pfizer has a track record of developing and getting vaccines approved, including on a short time line upon request of the FDA. Their vaccine development and manufacturing group is battle-tested and know what it takes - though this is gonna be big.
